Senior Director Compliance

Moonlaketx; United States; On-site; USD 250,000 - 350,000; Full time

Job summary

MoonLake seeks a Senior Director Compliance to serve as the senior internal compliance leader and day-to-day owner of the United States compliance program. This build role will design and implement a scalable, risk-based framework before first commercial interaction.

The successful candidate will lead MoonLake's compliance framework across US operations and, where relevant, European and Swiss activities, embedding seven program elements and driving launch readiness for growth and integrity.

Qualifications

• Design and implement a scalable, risk-based compliance framework for a launch-stage company.
• Lead policy development, training, monitoring and reporting activities.

Responsibilities

• Lead the implementation and ongoing improvement of MoonLake's United States compliance program, including Code of Conduct and policy suites.
• Own policy build-out and related tools, including advisory policies, and activity statements of work.
• Deliver pre-launch and launch readiness policies across promotional and non-promotional activities.
• Support the Compliance Committee and prepare quarterly reporting to leadership and the Board.
• Establish and maintain policy lifecycle, change logs, and cross-references across the policy suite.
• Ensure compliance with relevant US and international statutes and create an integrity-driven culture.

Skills

Regulatory compliance

Policy development

Governance

Training

Job description

The Senior Director Compliance will serve as MoonLake's senior internal compliance leader and the day-to-day owner of the United States compliance program. This is a build role rather than a maintenance role. MoonLake has no approved product currently on the market, and the successful candidate will be designing and implementing a scalable, risk-based compliance framework, policies, processes, forms, tools, training, monitoring, and transparency reporting, and embedding them in a lean and fast-moving organization before the first commercial interaction occurs. The role will lead and operationalize MoonLake´s compliance framework across its United States operations and, where relevant, its European and Swiss activities.

Key areas of responsibility include US healthcare fraud and abuse laws, including the Federal Anti-Kickback Statute and the False Claims Act; the Federal Food, Drug, and Cosmetic Act and FDA advertising and promotion requirements, including the restrictions that apply to a company with no approved product; federal and state transparency and aggregate spend reporting; federal exclusion and debarment screening; the United States Foreign Corrupt Practices Act; the EFPIA Disclosure Code and applicable national codes to the extent MoonLake's activities have European reach; the revised Swiss Federal Act on Data Protection and the EU General Data Protection Regulation as they apply to MoonLake's operations. In addition, the role will champion MoonLake's Code of Conduct and compliance policies, translating regulatory requirements into practical, risk-based controls that support the Company´s growth, launch readiness and culture of integrity. Consistent with the OIG's 2003 Compliance Program Guidance for Pharmaceutical Manufacturers and the OIG's 2023 General Compliance Program Guidance, the successful candidate will operationalize and continuously improve an effective program built around the seven elements, scaled appropriately for a launch-stage company of MoonLake's size, geographic reach, and risk profile. MoonLake currently receives compliance leadership on a fractional basis. The successful candidate will work alongside that resource during onboarding, will assume day-to-day ownership of the program, and is expected to become the company's permanent internal compliance lead.

Key Accountabilities Program build-out and governance

• Lead the implementation, own the execution and continuous improvement of MoonLake's United States compliance program, including the Code of Conduct, the compliance policy suite, and supporting standard operating procedures.
• Complete and assume ownership of the compliance policy build-out already in progress, including the non-promotional activities, advisory board, HCP engagement, patient advocacy and patient interaction, payer interaction, meals and hospitality, HCP travel and expense, medical legal and regulatory review, and speaker program policies, together with the Needs Assessment Form, the Fair Market Value Rate Matrix and tiering tool, and the HCP master agreement and activity statements of work.
• Deliver the promotional and commercial policy set ahead of approval and launch, ensuring organizational readiness across promotion, promotional speaker programs and the speaker bureau, congress and exhibits, personal services, samples, field interactions, social media, managed markets and contracting, and copay and patient support programs.
• Support the Compliance Committee.
• Develop agendas, document deliberations , and prepare quarterly reporting to executive leadership and to the Board on program effectiveness, risks identified, and remediation status.
• Own a documented policy lifecycle, including version control, a periodic review cadence, named policy owners, and a change log, and maintain consistent defined terms and cross references across the policy suite.
• Establish and maintain MoonLake´s compliance with state comprehensive compliance program statutes, including California Health and Safety Code sections 119400 to 119402, and prepare the annual written declarations of compliance.

Pre-approval and launch readiness

• Own the pre-approval compliance posture.
• Ensure that no communication represents an investigational product as safe or effective, that disease-state and scientific exchange activity remains non-promotional, and that the Company´s pre-launch activities do not constitute premature commercialization
• Advise on and govern the deployment of a pre-approval field organization, including the conduct guardrails that apply, the boundary between permitted disease-state education and impermissible promotion, escalation to Medical Information, and the transition of personnel into commercial roles upon approval.
• Govern pre-approval information exchange with payers and population health decision makers, and ensure that communications remain factual, balanced, and within the applicable framework.
• Build launch readiness against a defined timeline, so that policies, training